A Randomized, Open-label, Positive-controlled, Parallel-grouped, Multicenter Phase III Clinical Trial on the Efficacy and Safety of Flonoltinib Maleate Tablets in Patients With Intermediate- or High-risk Myelofibrosis
This trial adopts a multicenter, open label, positive drug parallel controlled clinical trial design, with a planned enrollment of approximately 105 participants in the MF trial. Successful trial participants were selected and assigned to either the experimental group or the control group in a 2:1 stratified manner, with the stratification factor being the Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria. Continuously take the test drug/control drug until it meets the withdrawal criteria.
• Age range of 18-80 years old (including threshold), gender not limited;
• Patients diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or patients diagnosed with post polycythemia vera myelofibrosis (PPV-MF) or post thrombocytopenia myelofibrosis (PET-MF) according to IWG-MRT criteria;
• Expected survival period greater than 24 weeks;
• ECOG score 0-2 points;
• Splenomegaly: Palpation of the splenic margin reaching or exceeding 5cm below the rib (distance from the intersection of the left clavicle midline and left rib margin to the farthest point of the spleen); Or due to physical reasons (such as obesity), it may not be palpable, but MRI/CT spleen evaluation during screening confirms a volume of \>= 450 cm\^3;
• Within 7 days prior to randomization, the main organ functions were generally normal, meeting the following criteria: ALT and AST \<= 2.5 × ULN; TBIL\<=2.0×ULN； Serum creatinine \<=1.5 × ULN or serum creatinine clearance rate (Ccr)\>50 mL/min; INR, PT, and APTT \<= 1.5 × ULN;
• Can understand and voluntarily sign an informed consent form.